Gelonghui, May 22丨Sitaili (603520.SH) announced that Shanghai Stari Pharmaceutical Co., Ltd. (“Shanghai Stari”), a wholly-owned subsidiary of the company, recently received the “Drug Registration Approval” for ioparol injections approved and issued by the China Drug Administration (“State Drug Administration”).
Indications for this drug include: neuroradiology: spinal radicography, brain fundurography, and ventriculography; angiography: cerebral angiography, coronary angiography, thoracic aortography, abdominal aortography, cardiovascular angiography, selective visceral arteriography, peripheral arteriography and ventriculography; digital subtraction angiography (D.S.A.) : Cerebral arteries D.S.A., peripheral arteries D.S.A., abdominal D.S.A.; urography: intravenous urography; enhanced scanning during CT; arthrography; fistula angiography, etc.
This drug is classified as a chemical drug in the drug registration category 4. According to the relevant provisions of the China Drug Administration's “Notice Concerning Matters Relating to the Consistent Evaluation of the Quality and Efficacy of Generic Drugs” (No. 100 of 2017) document,
This drug is considered to have passed the consistent evaluation of the quality and efficacy of generic drugs. The registration application for this drug was submitted and officially accepted on October 16, 2017. Up to now, the drug has invested a total of 11.5622 million yuan in research and development.
Iopadol was developed by Bracco (Bracco) in Italy. It is a monomer nonionic contrast agent with low toxicity to blood vessels and nerves, good local and systemic tolerability, low osmotic pressure, and stable injection solution. First listed in Italy in 1981, the product name is Iopamiro.
Iopadol is an X-ray nonionic iodine contrast agent. Similar varieties include iohexanol, iodoxanol, iopromide, and iomepril. According to data from the Newport Premium database, in 2018, the global X-ray contrast agent market size was about 4,042 billion US dollars, of which the main market share was concentrated in developed countries. Judging from the market performance of various types of X-ray contrast agents, iohydrol and iopadol are currently the best-selling contrast agents in the world. Among them, the global market size of ioparol in 2018 was about 685 million US dollars, and its main application markets were the US and Europe. According to data from the China Pharmaceutical Industry Information Center, the domestic X-ray contrast agent market size in 2019 was about 13.945 billion yuan, of which the iopadol market was about 1,513 billion yuan. Currently, there are 4 main domestic companies that sell iopanol injections: Bracco (Boleco), Shanghai Bolaike Xinyi Pharmaceutical Co., Ltd., Beijing Beilu Pharmaceutical Co., Ltd., and Guangzhou Kangchen Pharmaceutical Co., Ltd.
Shanghai Stary obtained the “Drug Registration Approval” for iopanol injections issued by the State Drug Administration, which marks the company's expansion from the existing industrial base to the downstream industry, which is conducive to the company's industrial integration and enhances the company's market competitiveness in the field of X-ray contrast agents.
According to the relevant agreement of the “Drug Cooperation Agreement” signed between the company and Jiangsu Hengrui Pharmaceutical Co., Ltd. (“Hengrui Pharmaceutical”) on May 11, 2020, the iopanol injection approved this time is a cooperative product between the two parties. Later, Hengrui Pharmaceutical will be responsible for the commercial operation of ioparol injections in the People's Republic of China (excluding Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan), including marketing and sales by itself or in cooperation with distributors. The company guarantees the exclusive supply of products to Hengrui Pharmaceutical within the agreed fields.